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Completed

NCT Number: NCT01333956

Effects of Pregabalin on Pain After Total Knee Arthroplasty

Total knee arthroplasty can cause severe postoperative pain, and patients typically receive oral opioid analgesics for over 2 weeks. Side effects of pain management may impair participation in physical therapy and diminish patient satisfaction. Anecdotally, it seems that pregabalin is very helpful to patients after total knee arthroplasty. However, pregabalin can have side effects. It is not clear how much pregabalin to prescribe. Low doses may not be effective, but use of high doses may increase the incidence and severity of side effects.The purpose of this study is to determine which dosage of pregabalin is the most effective at reducing pain after knee surgery.

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Key information

Conditions

Primary Total Knee Arthroplasty

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Hospital for Special Surgery

New York, 10021, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with osteoarthritis scheduled for primary tricompartmental total knee arthroplasty with a participating surgeon
  • Age 18 to 80 years old
  • Planned use of regional anesthesia
  • Ability to follow study protocol
  • English speaking (primary outcome obtained via telephone call and secondary outcomes include questionnaires validated in English only)
  • Patients planning on being discharged home or to a rehabilitation center that has agreed to participate

Exclusion criteria

  • Patients younger than 18 years old and older than 80
  • Patients intending to receive general anesthesia
  • Allergy or intolerance to one of the study medications
  • Patients with an ASA of IV
  • Patients with hepatic (liver) failure
  • Patients with chronic renal (kidney) failure (Defined as estimated creatinine clearance < 30 mL/min, based on recommendation that total daily pregabalin dose be reduced to 150 mg with Clcr < 30 mL/min, CLcr=[(140-age (years)] x weight (kg)x0.85 (for female patients)/[72xserum creatinine (mg/dL)])
  • Patients with difficult to manage diabetes mellitus, including insulin-dependence
  • Chronic gabapentin/pregabalin use (regular use for longer than 3 months)
  • Chronic opioid use (taking opioids for longer than 3 months)
  • Patients with major prior ipsilateral open knee surgery.
  • Chronic neurontin/lyrica use

Treatment and study plan

Pregabalin 50mg

Drug

Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.

Other names: Lyrica

Pregabalin 100mg

Drug

Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.

Other names: Lyrica

Pregabalin 150mg

Drug

Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.

Other names: Lyrica

Placebo

Drug

Patients will receive placebo drug with no active ingredients per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.

Primary outcomes

  1. Postoperative Pain

    Time frame: 2 weeks postoperatively

    Pain assessment scale (Numeric Rating Scale) (0=no pain; 10=worst pain imaginable).

Secondary outcomes

  1. Opioid-Related Symptom Distress Score

    Time frame: 2 weeks postoperatively

    Opioid-Related Symptom Distress score (ORSDS) measured at POD1 and POD14. The ORSDS is a 4-point scale that evaluates 3 symptom distress dimensions (frequency, severity, bothersomeness) for 12 symptoms. The symptom-specific ORSDS is the average of the 3 symptom distress dimensions. The composite ORSDS is the average of 12 symptom-specific scores. (0=low; 4=high).

  2. Self-assessed Sedation and Confusion

    Time frame: 1 day postoperatively

    Self-assessed sedation and confusion (POD1). Confusion Assessment Method (CAM score) (pre-operative and on POD1)

  3. Numeric Rating Scale (NRS)

    Time frame: 3 months

    NRS Pain (pre-operative, POD1, POD3, 2 weeks, 3 months, at orthopedic visits). Neuropathic pain incidence: Leeds assessment of neuropathic symptoms and signs (LANSS) score (3 months)

  4. Neuropathic Pain

    Time frame: 3 months

    Neuropathic pain incidence: Leeds assessment of neuropathic symptoms and signs (LANSS) score (3 months). Scale of 0 to 24. Higher values represent worse outcomes.

  5. Opioid Usage

    Time frame: 3 months

    Opioid Usage (POD1, POD 3, 2 weeks, 3 months)

  6. Satisfaction

    Time frame: 2 weeks

    Satisfaction with pain management (1-10 scale; 1 = very dissatisfied, 10 = very satisfied)

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Registry information

Official study title

Effects of Pregabalin on Pain After Total Knee Arthroplasty: A Randomized, Controlled, Double-Blind Trial

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Apr 12, 2011
Registry last updated
May 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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